Senior Clinical Data Manager/Principal Clinical Data Manager

Summary

Join Precision Medicine Group as a Senior or Principal Clinical Data Manager in a fully remote position (East Coast preferred). You will manage all aspects of clinical trial data management, from study start-up to post-database lock. Responsibilities include overseeing data entry, database development and testing, quality control, and documentation. You will also train personnel, review data, and liaise with vendors. This role requires significant experience in clinical data management and proficiency in various software and systems. Leadership and communication skills are essential.

Requirements

• Bachelor's degree and/or a combination of related experience
• 8+ years’ experience for a Sr. Clinical Data Manager and 10+ years for a Principal Clinical Data Manager
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
• Ability to handle a variety of clinical research tasks
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral
• Experience in utilizing various clinical database management systems
• Broad knowledge of drug, device and/or biologic development and effective data management practices
• Strong representational skills, ability to communicate effectively orally and in writing
• Strong leadership and interpersonal skills
• Ability to undertake occasional travel

Responsibilities

• Serve as the Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s)/program(s), ensuring back-up, continuity, responsiveness, and timely task completion
• Oversee the project data entry process, including developing data entry guidelines, training, ensuring data entry quality, and managing resources
• Perform quality control of data entry
• Provide input, assess, and manage timelines; ensure clinical data management deadlines are met with quality; assess resource needs for assigned projects, as needed
• Develop CRF specifications from the clinical study protocol and coordinate review/feedback from all stakeholders
• Assist in building clinical databases
• Conduct database build UAT and maintain quality controlled database build documentation; oversee the overall quality of the clinical database
• Specify requirements for all edit check types (e.g., electronic, manual data review, edit checks, etc.); oversee the development of edit check specifications and manual data review specifications
• Create, revise, appropriately version, and maintain data management documentation; oversee the completeness of data management documentation for the Trial Master File
• Train clinical research personnel on study-specific CRF, EDC, and other project-related items as needed
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review based on guidance provided by the sponsor and/or Lead DM
• Run patient and study-level status and metric reporting
• Perform medical coding of medical terms to ensure medical logic and consistency
• Coordinate SAE/AE reconciliation
• Liaise with third-party vendors (external data and EDC vendors) in a project-manager capacity to support timelines and data-related deliverables
• Assist with SAS programming and quality control of SAS programs used in the Data Management department
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• Assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSRs), if required by the project
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• Attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, and potential client engagement meetings
• Review Request for Proposals (RFPs), proposals, and provide project estimates
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• Train and ensure that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors, and project teams as needed regarding data, database, or other relevant project issues
• Present software demonstrations/trainings, department/company training sessions, and present at project meetings
• Perform other duties as assigned

Preferred Qualifications

• Experience in a clinical, scientific or healthcare discipline
• Dictionary medical coding (MedDRA and WHODrug)
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
• Oncology and/or Orphan Drug therapeutic experience

Benefits

100% remote position (East Coast preferred)